CLASS II Device recall · Reported 30 Oct 2024 · FDA Enforcement Report
A1CNow+ Multi-Test HbA1c System consists recalled
Polymer Technology Systems is recalling A1CNow+ Multi-Test HbA1c System consists of a semi-disposable plastic-encased device (the, distributed nationwide in the US. The recall was initiated on 18 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0223-2025
- FDA event ID
- 95416
- Recalling firm
- Polymer Technology Systems, Whitestown, IN
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 18 Sep 2024
- FDA classified
- 24 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Patient Monitors
Timeline
| 18 Sep 2024 | Recall initiated by company | |
| 24 Oct 2024 | Classified by FDA | +36 days |
| 30 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.
Product as listed by the FDA
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Japan, South Africa.
Questions about this recall
Is A1CNow+ Multi-Test HbA1c System consists of a semi-disposable plastic-encased device (the recalled?
Yes. Polymer Technology Systems recalled A1CNow+ Multi-Test HbA1c System consists of a semi-disposable plastic-encased device (the on 18 Sep 2024. The recall is Class II and its status is Completed. Recall number Z-0223-2025.
Why was it recalled?
The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.
Which lots are affected?
UDI-DI: 00381933021011 Lot Numbers: 9331803, 2323019
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Japan, South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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